Page 1 of 18

MDS – G11

Guidance on Approval Requirements

for Medical Devices Advertising

Version Number: 2.1

Version Date: 21/06/2021

Disclaimer: The English version is a translation of the original in Arabic for information purposes

only. In case of a discrepancy, the Arabic original will prevail.

Page 2 of 18

Table of Content

INTRODUCTION ........................................................................................................................... 3

Purpose ........................................................................................................................................ 3

Scope .......................................................................................................................................... 3

Background ................................................................................................................................. 3

GENERAL PROVISIONS .............................................................................................................. 4

APPLICANT RESPONSIBILITIES ............................................................................................... 6

REQUIREMENTS .......................................................................................................................... 7

First: Approval for advertising material directed to consumers: ................................................. 7

Second: Approval for advertising material directed to healthcare practitioners ....................... 10

ANNEXES .................................................................................................................................... 12

Annex (1): Approval form for advertising material directed to consumers .............................. 13

Annex (2): Approval form for advertising material directed to healthcare practitioners .......... 14

Annex (3): Definitions & Abbreviations ................................................................................... 15

Annex (4): How to issue an invoice for advertising of medical devices: .................................. 17

Annex (5): List of Changes on the Previous Version ................................................................ 18

Page 3 of 18

INTRODUCTION

Purpose

The purpose of this guidance is to specify and clarify requirements and procedures for

obtaining an approval for medical devices advertising.

Scope

This guidance is applicable to any medical devices intended to be advertised as well to the

following:

Local Medical Devices Manufacturers.

Authorized Represintitive of Medical Devices Manufacturers.

Medical Devices Distributers.

Medical Devices Importers.

Healthcare Providers importing Medical Devices.

Background

SFDA issued this guidance accordance to the folowing:

1. Article Five of “The Law of Saudi Food and Drug Authority” issued by the Royal

Decree No.(M/6) issued on 25/1/1428 H. The 5th item of the regulatory tasks stated

that “The SFDA sets controls and procedures that regulate inspection processes of

food and drug products, raw materials used for manufacturing them, medical

devices and all related to SFDA scope. It regulates advertising, importing and

exporting of these products, drug registeration, supervises and inspects markets,

shops and private wherehouse of these products in cooperation and coordination

with relavent parties”.

2. Article Forty One in Medical Devices Interim Regulation Issued by the Saudi

Food and Drug Authority Board of Directors decree number (1-8-1429) and

dated 29/12/1429 H, and amended by Saudi Food and Drug Authority Board of

Directors decree number (4-16-1439) dated 09/04/1439 H.

Page 4 of 18

GENERAL PROVISIONS

1. All medical devices advertising material shall be approved by the SFDA before its use

wheather directed to consumers or healthcare practitioners.

2. The Medical Device intended to be advertised shall be registereded in the SFDA.

3. The advertising material shall not mislead the user regarding the performance of

the Medical Devices as specified by the manufacturer.

4. The advertising material shall not contain claims that are not approved by the

SFDA. This is when a seperate approval is obtained from advertising licening

section.

5. When the advertising material is prepared and submitted by a distributer or

importer on its own behalf, they shall obtain before applies for an approval:

o An establishement National Registry Number/ an establishement account

in GHAD.

o Medical Devices Establishment Licensing (The Healthcare providers who

import Medical Devices are not required to have it).

6. The advertising material shall meat the need of Medical Devices consumers.

7. The advertising material shall contains the following:

o The name of the medical device/supply.

o The name and address of manufacturer.

o MDMA certificate number (Required in case the advertising approval was

part of MDMA procedure).

o The advertising approval number (It is required in case of separate

approval).

8. The SFDA name or logo or any name or logo of other internal or external

regulatory body shall not directly or indirectly used in the advertisement content.

9. The advertising material shall not contains establishement National Registry

Number / establishement account in GHAD.

10. Establishment can delegates a licensed advertising agency to apply for advertising

approval on their behalf and the delegation has to be authenticated by Chamber of

Commerce .

11. The advertising material shall not violates “Law of Printed Materials and

Publications” in KSA.

Page 5 of 18

12. Content of the advertisement material shall adhere to the community customs and

values. It shall not violates public decency.

13. The advertising material shall not contains any offensive words against the

competing medical devices.

14. The advertising material shall not contains any comparison with other competing

companies products.

15. The manufacturers, ARs, distributers and importers are responsible for ensuring

their medical sales representitives/ promoters have sufficient knowledge and they

are able to provide appropriate information about the medical devices they

promote.

16. New request for approval of advertising shall be submitted if desired to modify an

approved advertising format or renew an approved advertising format in case of

separate approval obtained from advertising licensing section.

17. Apllication for seminar or workshop of a medical device/supply shall be

submitted before 20 days as a minimum. In case the content of the seminar or the

workshop has been aproved, the exact content can be used for one Hijri year in

different places without adding or modifiying the approved content and format.

18. No other approval is required when changing the display medium only for the

pre-approved advertisement while keep the same format and content and the

validity of the approval.

19. Advertising for primary device and its accessories is consider as one advertising

regarding fees. In case the advertising is for an accessory without the primary

device the fees shall be paid. However, In case of several devices included in one

application, a fees shall be paid for each device in case of separate approval

obtained from advertising licensing section.

20. The local manufacturers and AR are responsible of the following:

a) Ensuring all the advertising materials (either newly prepared material or

revised versions of the material submitted was part of MDMA procedure) are

approved by the SFDA before they are used by them or by importers or

distributers.

b) Providing importers and distributers (if applicable) a copy of all approved

advertising materials and specify the following:

o Target audience: “Consumers” or “Healthcare practioners”.

o Display medium such as (newspapers, magazines, TVs, Radio, Internet),

social media (YouTube, Twitter, Facebook, Instagram, Snapchat) and

others.

Page 6 of 18

APPLICANT RESPONSIBILITIES The Applicant is responsible for the following:

Obligate to compliance with the Medical Devices Interim Regulation and to the

requirements and general provisions mentioned in this guidance and the related

generlizations issued by the SFDA.

Obligate to all related regulations and laws submitted by other related parties.

Not produce the advertising material before obtaining the approval from the

SFDA.

Not use the advertising materials after the expiration date in case of separate

approval obtained from advertising section.

Contain the approval number of the Medical Device for advertising material. This

does not apply in case the advertising was part of MDMA procedure.

Not adding or deleting or modifying the format of the advertising material after

obtaining the approval.

Any modification, including translation, will require a new approval.

Terminate the advertisement when any new information indicates the presence of

risks resulted from the device or its inaffectiveness or when the SFDA request for

termination with justified reasons.

Notify the AR and the manufacturer (if applicable) of the medical device that is

intended to be advertised about the request.

The Establishment bears the consequenses resulted from the mislead informations

or claims within the advertising material regardless of the approval.

Page 7 of 18

REQUIREMENTS

First: Approval for advertising material directed to consumers:

General

Requirements

1 The advertising material shall not mislead the user regarding the

performance of the medical device as specified by the manufacturer.

2 The advertising material shall avoid misleading lay persons or the

advertising to the general public, including the internet.

3 The advertising material shall not include phrases that might be

misinterpreted.

4 The advertising material shall be in Arabic, English content can be

used if it is identical to the Arabic content.

5 Advertising material shall be approved in case submitted through TV

channels or radios stations that is located in KSA and directed to the

Saudi public.

Particular

Requierment for

Advertising on

Internet and

Social Media

Platforms

6 Advertising material shall be approved when published by individuals

through Social Media.

7 Advertising material shall be approved in case published through

Internet or social media and directed to the public in KSA either

website or social media platform is registered inside or outside KSA.

8 The advertising material shall be available on the website itself

without relating to any external links.

9 The website shall not connect the browser with other links or websites

that contain additional information or different advertising materials

unless they are previously approved.

10 Information directed to healthcare practitioners shall not delivered

through websites dedicated to consumers.

11 In case advertising material is published by individuals on social media

platforms, SFDA shall be notified by a maximum of 12 hours prior to

publication through the email (AD.L@sfda.gov.sa) with providing the

advertiser’s name and social media account.

Page 8 of 18

12 The social media advertising material shall not contains any

comments, replies ,tweets ,inquiries, publications or any additional

advertising materials unless it is previously approved, including using

Hashtag (#).

13 The script shall be presented as a copy of advertising material of the

visual advertisement if casted live (not recorded).

Contract

between

Establishment

and Social

Media

Advertiser

14 - A contract shall be signed between the two parties

(establishment and advertiser) including the following:

1. The content of advertising material.

2. The time period of displaying the advertising material.

3. Validity period of the contract.

4. Publication date of the advertising material.

5. Publication median

(TV/Radio/Newspapers/Magazines/Leaflets/Billboards/

SMS/Social Media Platforms (Twitter/Instagram/Snapchat/

YouTube) or others).

- Attach the contract when requesting approval.

- Two copies of the contract shall be signed and kept by each of

the parties.

- Allocating the geographical scope of the advertisement.

Submission

Procedure and

Required

Documents

15 There are two situations for submitting of advertising material:

A. as a part of MDMA procedure, the applicant is required to

submit all the advertising material that will be used in the

KSA. This situation is applicable when the advertising

material:

- prepared and submitted by a local manufacturer, or

- prepared by an overseas manufacturer and submitted by

its AR.

B. obtaining separate approval for advertisement of Medical

Devices. In this case, the approval for advertising is requested

by following these steps:

First: Preparing the request containing the following:

- Official letter written in Arabic language stamped by the

company and directed to SFDA.

- Proof of medical device registeration in SFDA.

- Approval form for advertising material directed to

consumers (see Annex 1).

- A copy of advertising material.

- Documents supporting claims in case where advertising

material contains any claims (e.g., FASTER, BEST …

Page 9 of 18

etc). These documents shall be valid and issued by

eminent bodies.

Second: Submitting the request through these steps:

- Submitting the request to the Advertising Approval

Section in Operation Sector so that all the required

documents mentioned above shall be printed. In addition

to attach CD that contains all documents mentioned above.

- Sending the request in PDF format to the email:

Communication.Adm@sfda.gov.sa . Attach the document

as one file so that the official letter shall be in the first page

of the document. Request tracking number will be

assigned and provided to the applicant.

Time required to process approval from Advertising Approval

Section is (10) working days.

16 After receiving the request, it is verified to fulfill the requirements and revise

the content. When there is no comment or shortfalls, the approval is issued.

Fees 17 Three thousands (3000) SAR for each medical device in each

advertising format when a separate approval is obtained from

Advertising Approval section.

Page 10 of 18

Second: Approval for advertising material directed to healthcare

practitioners

The advertising material shall be written in English language and Arabic

language is allawed to be used when it matching the English content.

1 Requirements

Obligate to the requirements and instructions produced by other relevent

parties in case holding lectures or seminars of the medical device

including online lectures and seminars.

2

There are two situations for submitting of advertising material:

A. as a part of MDMA procedure, the applicant is required to submit

all the advertising material that will be used in the KSA. This

situation is applicable when the advertising material:

- prepared and submitted by a local manufacturer, or

- prepared by an overseas manufacturer and submitted by its

AR.

B. obtaining separate approval for advertisement of Medical Devices.

In this case, the approval for advertising is requested by following

these steps :

First: Preparing the request containing the following:

- Official letter written in Arabia with stamped by company and

directed to SFDA.

- Proof of medical device registeration in SFDA.

- Approval form for advertising material directed to consumers.

(see Annex 2).

- A copy of advertising material.

- Documents supporting claims in case where advertising

material contains any claims (e.g., FASTER, BEST … etc).

These documents shall be valid and issued by eminent bodies.

- In case of holding lectures or seminars of medical devices, it

shall be added to the documents mentioned previously:

o A copy of the hall reservation.

o CV of the presenters.

o Presenter’s proof of identity (National ID, Iqama,

Passport).

Second: Submitting the request through these steps:

- Submitting the request to the Advertising Approval Section in

Operation Sector so that all the required documents mentioned

above shall be printed. In addition to attach CD that contains

all documents mentioned above.

3 Submission

Procedure and

Required

Documents

Page 11 of 18

- Sending the request in PDF format to the email:

Communication.Adm@sfda.gov.sa . Attach the document as

one file so that the official letter shall be in the first page of the

document. Request tracking number will be assigned and

provided to the applicant.

Time required to process approval from Advertising Approval Section

is (10) working days.

After receiving the request, it is verified to fulfill the requirements

and revise the content. When there is no comment or shortfalls, the

approval is issued.

4

Six thousands (6000) SAR for each medical device in each

advertising format, lectures or seminars for the medical device when

a separate approval is obtained.

5 Fees

Page 12 of 18

ANNEXES

Page 13 of 18

Annex (1): Approval form for advertising material directed to

consumers

المنشأة نشأةاسم الم مصنَع ممثل قانوني مستورد نوع المنشأة موزع

رقم السجل الوطني للمنشأة

رقم ترخيص المنشأة

الجهاز/المنتج الطبي اسم الجهاز/ المنتج الطبي

في السجل قيد المنتج الطبيرقم

ذن والمتضمن في شهادة ال الوطني

بتسويق الأجهزة والمنتجات الطبية

أو رقم تسجيل المنتج

مقروء مسموع مرئي نوع الإعلان

*)لا يمكن تحديد أكثر من خيار واحد(

إذاعة تلفاز ( إنترنتشبكة عنكبوتية)

صحف مجلات مواد للمعارض

محركات البحث موقع إلكتروني

)منصات التواصل الاجتماعي )يجب التحديد

يوتيوب فيسبوك تويتر سناب شات انستقرام

أخرى .................................

وسيلة العرض

............................. ............................... ............................... ................................. التواصل منصاتفي الأفراد اسم حساب المعلن من

الاجتماعي

من مسؤولية التأكد من أن المادة أقر بأن الحصول على موافقة الدعاية والعلان لا يعفي المنشأة .1

الدعائية والعلانية ومن أن الأجهزة والمنتجات الطبية المراد العلان عنها متوافقة مع لائحة رقابة

.الأجهزة والمنتجات الطبية وأي اشتراطات ومتطلبات أصدرتها الهيئة

.الموافقة عليهاالعلانية بعد دم تعديل صيغة المادة الدعائية و ع .2

الأجهزة والمنتجات اتالعلان على أي معلومات مضللة للمستخدم عن إمكان و أتحتوي الدعاية لا أ .3

.الطبية المحددة من قبل المصنع

تجنب التغرير بالمستخدم العادي في المواد الدعائية والعلانية والمنشورات الموجهة للمجتمع بما في .4

.ذلك المعلومات على الشبكة العنكبوتية

واد الدعائية والعلانية والمنشورات الموجهة للأشخاص المعنيين باستخدام الأجهزة أن تحتوي الم .5

.والمنتجات الطبية على المعلومات المتوافقة مع احتياجاتهم

علان عنه بهذا الطلب.ال الدعاية و إبلاغ الممثل القانوني للجهاز/المنتج الطبي المراد .6

التعهد

الختم

...............................................مدير عام المنشأة/ المفوض:

................................................................................ التاريخ:

..............................................................................التوقيع:

Page 14 of 18

Annex (2): Approval form for advertising material directed to

healthcare practitioners

المنشأة اسم المنشأة موزع مصنَع ممثل قانوني لمصنَع نوع المنشأة مستورد

رقم السجل الوطني للمنشأة

رقم ترخيص المنشأة

الجهاز/المنتج نتج الطبياسم الجهاز/ الم

والمتضمن في المنتج الطبيالجهاز/قيد رقم الطبي

شهادة الذن بتسويق الأجهزة والمنتجات

نتجالم تسجيلرقم أو الطبية

مقروء مسموع لا يمكن تحديد أكثر من خيار واحد(نوع الإعلان مرئي(

نشرات علمية كترونية مخصصة للممارسين الصحيينمواقع إل

جلات والمالصحف أو الذاكرة الفلاشية الاسطوانات المدمجة

بريد إلكتروني ......................................................أخرى.....................

وسيلة العرض

العنوان

ة أو المحاضر

الندوة

التعريفية

بالجهاز/المنتج

الطبي

الغرض

اسم البرنامج أو التطبيق /المكان

اللكتروني للمحاضرة المرئية

التاريخ

ر المحاضاسم

يراعى التقيد باشتراطات وتعليمات نتج الطبيالتعريفية بالجهاز/الم ة أو الندوةحاضر المفي حال إقامة ملاحظة:

.الجهات المعنية الأخرى ذات العلاقة

أقر بأن الحصول على موافقة الدعاية والعلان لا يعفي المنشأة من مسؤولية التأكد من أن المادة الدعائية والعلانية ومن أن .1

حة رقابة الأجهزة والمنتجات الطبية وأي اشتراطات ومتطلبات الأجهزة والمنتجات الطبية المراد العلان عنها متوافقة مع لائ

أصدرتها الهيئة.

.الموافقة عليهاالعلانية بعد دم تعديل صيغة المادة الدعائية و ع .2

.الأجهزة والمنتجات الطبية المحددة من قبل المصنع اتتحتوي الدعاية والعلان على أي معلومات مضللة عن إمكان ألا .3

د الدعائية والعلانية والمنشورات الموجهة للأشخاص المعنيين باستخدام الأجهزة والمنتجات الطبية على تحتوي الموا ألا .4

.المعلومات المتوافقة مع احتياجاتهم

الأشخاص المعنيين بتسويق الأجهزة والمنتجات الطبية المعلومات الكافية عنها بما يكفل تقديم ممثلي المبيعات/أن يكون لدى .5

لصحيحة الخاصة بتسويقها.المعلومات ا

علان عنه بهذا الطلب.ال الدعاية و إبلاغ الممثل القانوني للجهاز/المنتج الطبي المراد .6

التعهد

الختم

...............................................مدير عام المنشأة/ المفوض:

................................................................................ التاريخ:

..............................................................................التوقيع:

Page 15 of 18

Annex (3): Definitions & Abbreviations

KSA Kingdom of Saudi Arabia

SFDA Saudi Food and Drug Authority

Medical Device

Means any instrument, apparatus, implement, machine, appliance,

implant, in vitro reagent or calibrator, software, material or other

similar or related article:

A) Intended by the manufacturer to be used, alone or in combination,

for human beings for one or more of the specific purpose(s) of:

- Diagnosis, prevention, monitoring, treatment or alleviation of

disease,

- Diagnosis, monitoring, treatment, alleviation of or compensation

for an injury or handicap,

- Investigation, replacement, modification, or support of the anatomy

or of a physiological process,

- Supporting or sustaining life,

- Control of conception,

- Disinfection of medical devices,

- Providing information for medical or diagnostic purposes by means

of in vitro examination of specimens derived from the human body;

and

B) Which does not achieve its primary intended action in or on the

human body by pharmacological, immunological or metabolic means,

but which may be assisted in its intended function by such means.

Manufacturer Means any natural or legal person with responsibility for design and

manufacture of a medical device with the intention of making it

available for use, under his name; whether or not such a medical

device is designed and/or manufactured by that person himself or on

his behalf by another person.

Authorized

Representative (AR)

any legal person established within the KSA who has received a

written mandate from overseas manufacturer to act on his behalf in

the KSA with relation to implement provisions of law and executive

regulation.

Importer Means any natural or legal person established within the KSA that

places a device from a third country on the KSA market.

Page 16 of 18

Distributer Means any natural or legal person in the supply chain who, on his own

behalf, furthers the availability of a medical device to the end user.

Establishment any place of business within the KSA that is involved in the

manufacture, and/or placing on the market, and/or distribution of

medical devices; or acting on behalf of the manufacturer.

Advertising of

Medical Devices

means any form of information, canvassing activity or inducement

intended to promote the supply or use of medical devices.

Medical Devices

National Registry

(MDNR)

is the database of registered establishments and the medical devices

they manufacture or import or distribute.

National Registry

Number

means the number issued to a person by the SFDA under the

establishment registration provisions of the Medical Devices Interim

Regulation.

Medical Device

National Listing

Number

means the code assigned by the SFDA to a single medical device, that

has been included in a marketing authorization application, to indicate

the device is authorized to be placed on the KSA market and facilitate

traceability.

Licensing

Establishment

Number

means the number issued by the SFDA to an establishment to allow

for importing or distribution or represent a manufacturer.

MDMA Medical Device Marketing Authorisation

Page 17 of 18

Annex (4): How to issue an invoice for advertising of medical devices:

1. Enter the Billing System for SFDA services.

2. Go to the option “issue an invoice”.

3. Go to the option “department name”.

4. Choose the advertising licensing section.

5. Go to the service type and choose the service.

6. Fill in the establishment name field.

7. Fill in the name of the medical device.

8. To finish, click on the option of issue an invoice.

Page 18 of 18

Annex (5): List of Changes on the Previous Version

Number & Date

of the Previous Version

Changes

1.1

1/5/2016

Adding Medical Devices Importers to the scope.

Adding a clause “GENERAL PROVISIONS”.

Adding a clause “APPLICANT RESPONSIBILITIES”.

Adding a clause “Patricular Rquierment for Advertising on

Internet and Social Media Platforms”.

Adding applying fee for Advertising materials directed to

consumers, or directed to healthcare practitioners whenever

request a separate approval from Advertising Approval Section.

Adding a new channel for receiving application through email.